NL-OMON44006已完成3 期
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve. - CENTERA 2014-03
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on eligibility including assessment that TAVI is appropriate.
- •2. High surgical risk: 8 <= STS Score <= 15 or 15 <= Logistic EuroSCORE I <= 40.
- •if STS score is below 8 and/or EuroSCORE is below 15,the Heart Team must document other clinical or anatomical risk factors for which the patient would be considered high risk for surgery.
- •3. NYHA >= II.
- •4. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by AVA <= 1cm2 (or indexed AVA <0.6 cm2/m2) or mean gradient > 40mmHg (or peak aortic jet velocity > 4.0m/sec).
- •5. Study patient is an adult of legal consent age.
- •6. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
- •7. If women of childbearing age, confirmation of negative pregnancy test
排除标准
- •1. Evidence of an acute myocardial infarction <= 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with elevation of CK-MB >= 3 times normal in the absence of pathological Q waves), if no assay for CK-MB was performed, elevation of CK level to > 2 times normal without new Q waves is also considered a non-Q wave MI)].
- •2. Untreated clinically significant coronary artery disease requiring revascularization.
- •3. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- •4. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- •5. Preexisting bioprosthetic valve or ring in any position.
- •6. Leukopenia (WBC < 3000 cell/µL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/µL), or any known blood clotting disorder.
- •7. Non-valvular hypertrophic cardiomyopathy with or without obstruction (HOCM).
- •8. Severe ventricular dysfunction with LVEF < 20%.
- •9. Echocardiographic evidence of intracardiac or intraaortic mass, thrombus or vegetation.
- •10. Active upper GI bleeding within 3 month (90 days) prior to procedure.
- •11. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
- •12. Native aortic annulus size < 18 mm or > 26 mm as measured by CT.
- •13. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
- •14. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
- •15. Estimated life expectancy < 24 months (730 days) due carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
- •16. Expectation that patient will not improve despite treatment of aortic stenosis.
- •17. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- •18. Active infection at the time of procedure and/or bacterial endocarditis within 6 months (180 days) of procedure.
- •19. Access vessel characteristics that would preclude safe placement of a minimum 14F sheath, which may include any of the following: severe obstructive calcification, severe tortuosity, or minimum vessel diameter less than 0.5mm.
- •20. Known hypersensitivity to nitinol (nickel or titanium) or contrast media that cannot be adequately premedicated.
- •21. PCI within one month (30 days) prior to the TAVI procedure.
- •22. Emergency interventional/surgical procedures within one month (30 days) prior to the TAVI procedure.
- •23. Severe mitral insufficiency.
- •24. Pregnant or breastfeeding women
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